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NCT01410227 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT01410227: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT01410227 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 49 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01410227, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary von Willebrand disease (VWD).
Primary Outcome
Treatment success was defined as the extent of control of bleeding episodes (BEs) using a mean efficacy rating score of \<2.5 for a participant's BEs treated with study product (recombinant von Willebrand Factor \[rVWF\] with or without recombinant factor VIII \[rFVIII\]) during the study period. Scores used: Excellent = 1 - actual infusions ≤ estimated number of infusions required to treat BE; no additional VWF required (all BEs); Good = 2 - \>1-2 infusions (minor/moderate BEs) or \<1.5 infusio
Interventions
- DRUG Placebo
- BIOLOGICAL Recombinant von Willebrand factor (rVWF)
- BIOLOGICAL Recombinant factor VIIII (rFVIII)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2011-11-01 |
| Est. Completion | 2014-02-01 |
| Phase | Phase 3 |
What the finished NCT01410227 record still lists
NCT01410227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01410227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01410227 about?
NCT01410227 is a clinical study titled "Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)". The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary von Willebrand disease (VWD).
What is the current status of trial NCT01410227?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2011-11-01. Estimated completion is 2014-02-01.
What interventions are being tested in trial NCT01410227?
The interventions under investigation include: Placebo (DRUG), Recombinant von Willebrand factor (rVWF) (BIOLOGICAL), Recombinant factor VIIII (rFVIII) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01410227?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01410227's enrollment target sits among peer trials
49 1860th of 2000 higher than 139 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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